Assessment of Colostomy Bags With an Active Chamber Filter System and Incidence of Filter-Related Complication
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Confidence Be 1-Piece Closed Bag, Confidence Natural 1-Piece Closed Bag, Confidence Be go 1-Piece Closed Bag.
- Who it may be relevant to
- Registry conditions: Colostomy - Stoma, Colostomy Complications. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Three Way Crossover Study: Assessment of Colostomy Bags With an Active Chamber Filter System and Incidence of Filter-Related Complication by People Living With a Colostomy
Overview
This 3-way crossover study aims to evaluate whether colostomy bags with an active chamber filter system reduce the incidence of filter-related complications, such as ballooning and pancaking, help neutralise odour, and minimise faecal leakage through the filter compared to colostomy bags with a protective filter
Detailed description
The study will recruit participants living with a colostomy who experience complications related to colostomy bag filters. The study follows a repeated-measures design, in which each participant will test three types of colostomy bags (A, B, and C) over a 21-day period, divided into three 7-day test periods. During each test period, participants will use one type of colostomy bag for 7-days or up to 21 closed bags. Participants will be instructed to change the colostomy bag as often as they normally would or whenever they deem it necessary
Interventions
- Device Confidence Be 1-Piece Closed Bag
Active Chamber Filter - Circle Shape - Device Confidence Natural 1-Piece Closed Bag
Protective Filter - Circle Shape - Device Confidence Be go 1-Piece Closed Bag
Active Chamber Filter - Hexagon Shape
Primary outcome measures
- Incidence of ballooning [Time frame: 21-days]
Secondary outcome measures (7)
- Time of ballooning incidence [Time frame: 21-days]
- Wear time until ballooning incidence [Time frame: 21-days]
- Incidence of pancaking [Time frame: 21-days]
- Time of pancaking incidence [Time frame: 21-days]
- Wear time until pancaking incidence [Time frame: 21-days]
- Faecal leakage occurrence through the filter [Time frame: 21-days]
- Occurrence of odour through the filter [Time frame: 21-days]
Eligibility criteria
Inclusion criteria
- Adult aged over 18 years
- Colostomy for 6 months or longer
- Experiences any filter-related complications, such as ballooning, pancaking, odour, or faecal leakage through the filter, at least once a week (7 days)
- Independent in colostomy care
- Using a flat, closed colostomy bag
- Stoma size (diameter) less than 55 mm
- Using a colostomy bag with a hydrocolloid wafer (baseplate)
- Able to read and complete the study questionnaire in English
Exclusion criteria
- Uses colostomy irrigation
- Bleeding or broken peristomal skin
- Receiving or had radiotherapy or chemotherapy in the last 2 months
- Pregnant or breastfeeding
- Taking part in another clinical study
- Currently receiving treatment under the care of a stoma clinical nurse specialist
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United Kingdom · 1 center
- Central Skin Sciences Institute (CSSI) Salts Healthcare — Birmingham
Identifiers
NCT: NCT06739174 · 24/EE/0241